| Job Description | • Management & deployment of key Quality System elements viz., Change Control, Non Compliance(NC)/Corrective & Preventive Action (CAPA), Consumer Complaints, • Process/Method Validations, Stability studies, GMP/GLP training, Facility/Utility/Equipment Qualifications, Process Control, In Process Quality Assurance(IPQA )etc. • Implementation of various company Quality Policies at Location. To ensure that the plants are operating as per Regulatory requirements. • To optimize various quality systems, Implementation of cGMP systems in the plant as per national and international regulatory requirements. • Technical support to regulatory affairs to reply for the regulatory queries as and when required. Vendor Audits Management. • Reduction in analysis time of RM, vendor samples, Intermediates, and finished products by effective utilization of available equipments. • To plan for the process validations, and cleaning validations for the existing and incoming products along with production. | ||||
| Desired Profile | • Should have good exposure in Change Management System, Deviation/ Incidences handling, internal quality audits & GMP audit system, Annual Product Review, Vendor audits and qualifications, Market complaints. Training, Returned product investigation, Technology transfer and new product launch, Risk analysis & CAPA, and Preparation of audits and audit compliance • Should be having adequate exposure of Regulatory Audits. • Candidate must possess an excellent communication Skills | ||||
| Experience | 12 - 15 Years | ||||
| Industry Type | Pharma, Biotechnology, Clinical Research | ||||
| Role | Quality Assurance/ Quality Control Manager | ||||
| Functional Area | Production, Maintenance, Quality | ||||
| Education | UG - Any Graduate - Any Specialization, Graduation Not Required PG - M.Pharma, M.Sc | ||||
| Location | Indore | ||||
| Keywords | Excellent Communication, Team Leadership Skills | ||||
| Contact | Mahendra Singh Cipla Ltd | ||||
| Website | http://www.cipla.com/ | Apply |
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